Dislodger, Stone, Biliary
FDA adverse event reports and recall history for dislodger, stone, biliary (product code LQR), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 841
- Deaths
- 5
- Injuries
- 135
- Malfunctions
- 698
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-04-06Open, ClassifiedIncorrect or no expiration date
COOK MEDICAL Cook Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2026-04-06Open, ClassifiedIncorrect or no expiration date
COOK MEDICAL NCompass Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- 2009-03-11TerminatedPackaging
Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 20 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3511. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.
The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated.
- 2009-03-11TerminatedPackaging
Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 5.5 Fr, 30 mm, 11.5 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3513. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.
The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated.
- 2009-03-11TerminatedPackaging
Boston Scientific Stonetome Stone Removal Device. Triple Lumen Sphincterotome, 11.5 mm, 5.5 Fr, 20 mm, sterile, Boston Scientific Corp., Natick, MA; REF 3515. The device is used in diagnostic or therapeutic endoscopic retrograde cholangiopancreatography, transendoscopic sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi, to remove stones from the biliary system, and to facilitate injection of contrast medium while occluding the duct with the balloon.
The ultraviolet light barrier on the pouch may be discolored, which will allow ultraviolet light into the package and may cause the latex retrieval balloon to become brittle and to leak or burst when inflated.
- 2006-06-27TerminatedOther
Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, distal balloon, sterile, single use only, material number M00535110; catalog number 3511.
Lack of assurance of sterility, as the sterile barrier may fail.
- 2006-06-27TerminatedOther
Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 30 mm cut wire, distal balloon, sterile, single use only, material number M00535130; catalog number 3513.
Lack of assurance of sterility, as the sterile barrier may fail.
- 2006-06-27TerminatedOther
Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535150; catalog number 3515.
Lack of assurance of sterility, as the sterile barrier may fail.
- 2006-06-27TerminatedOther
Boston Scientific Stonetome Stone Removal Device, 20 mm tip, 20 mm cut wire, proximal balloon, sterile, single use only, material number M00535170; catalog number 3517.
Lack of assurance of sterility, as the sterile barrier may fail.
- 2006-06-27TerminatedOther
Boston Scientific Stonetome Stone Removal Device, 5 mm tip, 30 mm cut wire, proximal balloon, sterile, single use only, material number M00535190; catalog number 3519.
Lack of assurance of sterility, as the sterile barrier may fail.
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